U.S. patent number 7,540,879 [Application Number 10/204,251] was granted by the patent office on 2009-06-02 for endolumenal device for delivering and deploying an endolumenal expandable prosthesis.
This patent grant is currently assigned to E.V.R. Endovascular Researches S.A.. Invention is credited to Alessandro Loaldi.
United States Patent |
7,540,879 |
Loaldi |
June 2, 2009 |
**Please see images for:
( Certificate of Correction ) ** |
Endolumenal device for delivering and deploying an endolumenal
expandable prosthesis
Abstract
An endolumenal device (1) for delivering and deploying an
endolumenal expandable prosthesis (6) at a bifurcation provided
with a main conduit and at least a secondary conduit, comprises an
elongated body (2) having a proximal end portion (4) and a distal
end portion (3); the distal end portion (3) comprising expansion
means (5) having a longitudinally extended active portion removably
engageable with the prosthesis (6). Said active portion of the
expansion means to longitudinally associated to the body in order
to expand said prosthesis eccentrically from one side with respect
to the body, in order to leave free from said expanded active
portion the other side of the body. The device further is provided
with guidewire tracking means (11).
Inventors: |
Loaldi; Alessandro (Milan,
IT) |
Assignee: |
E.V.R. Endovascular Researches
S.A. (Luxembourg, LU)
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Family
ID: |
8171046 |
Appl.
No.: |
10/204,251 |
Filed: |
December 19, 2000 |
PCT
Filed: |
December 19, 2000 |
PCT No.: |
PCT/EP00/12964 |
371(c)(1),(2),(4) Date: |
November 26, 2002 |
PCT
Pub. No.: |
WO01/60284 |
PCT
Pub. Date: |
August 23, 2001 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20030187494 A1 |
Oct 2, 2003 |
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Foreign Application Priority Data
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Feb 18, 2000 [EP] |
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00200572 |
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Current U.S.
Class: |
623/1.11;
623/1.35 |
Current CPC
Class: |
A61F
2/954 (20130101); A61F 2/958 (20130101); A61F
2/856 (20130101); A61F 2002/9583 (20130101); A61F
2250/0087 (20130101); A61F 2250/0085 (20130101); A61F
2002/067 (20130101) |
Current International
Class: |
A61F
2/06 (20060101) |
Field of
Search: |
;606/194,108,192
;623/1.11,1.12,1.35 ;604/96.01 ;600/583,104 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0891751 |
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Jan 1999 |
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EP |
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0 897 700 |
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Feb 1999 |
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EP |
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0 897 700 |
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Jul 2002 |
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EP |
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3004480 |
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Aug 1993 |
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JP |
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2108764 |
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Apr 1998 |
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RU |
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2121317 |
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Nov 1998 |
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RU |
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WO 95/01202 |
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Jan 1995 |
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WO |
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WO 96/34580 |
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Nov 1996 |
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WO |
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WO 97/04829 |
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Feb 1997 |
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WO |
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WO 97/45073 |
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Dec 1997 |
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WO |
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98/36709 |
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Aug 1998 |
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WO |
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WO 99/03426 |
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Jan 1999 |
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WO |
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99/15103 |
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Apr 1999 |
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WO |
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WO 99/44539 |
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Sep 1999 |
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WO |
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WO 00/74595 |
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Dec 2000 |
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WO |
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01/78621 |
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Oct 2001 |
|
WO |
|
Other References
International Search Report of PCT Application No. PCT/EP 00/12964
mailed Jul. 26, 2001 in 6 pages. cited by other .
International Search Report of PCT Application No. PCT/IB03/01178
mailed Aug. 4, 2003 in 7 pages. cited by other.
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Primary Examiner: Woo; Julian W
Attorney, Agent or Firm: Knobbe Martens Olson & Bear
LLP
Claims
The invention claimed is:
1. Endolumenal device for delivering and deploying an endolumenal
expandable prosthesis at a bifurcation provided with a main conduit
and at least a secondary conduit, comprising: an elongated body
having a proximal end portion and a distal end portion; the distal
end portion of said elongated body comprising an expandable portion
having a proximal end and a distal end, the expandable portion
engageable with the endolumenal expandable prosthesis and adapted
to adjust said prosthesis from a radially collapsed condition to a
radially expanded condition; a guidewire tracking device at least
partially extending along said elongated body; wherein said
expandable portion being longitudinally associated to the elongated
body in order to expand said prosthesis eccentrically from one side
with respect to the elongated body, and said guidewire tracking
device comprises at least a guidewire lumen at least partially
extending inside said elongated body, having a plurality of
guidewire distal ports comprising a first guidewire distal port and
a second guidewire distal port, the first guidewire distal port and
the second guidewire distal port being in communication with the
same lumen and opening to an outside of the endolumenal device to
be in fluid communication with a blood vessel in use, said first
guidewire distal port provided on a side of the elongated body
opposed to the expandable portion and suitable for slipping through
it a guidewire portion of at least a guidewire placeable with its
distal portion in said main or at least a secondary conduit, said
second guidewire distal port provided on a side of the elongated
body opposed to the expandable portion for slipping through it a
guidewire portion; wherein each of the first guidewire distal port
and the second guidewire distal port is located between the
proximal end and distal end of the expandable portion.
2. Endolumenal device according to claim 1, in which said at least
a guidewire lumen extends completely inside said elongated
body.
3. Endolumenal device according to claim 1, in which said
expandable portion is entirely associated to the elongated body in
order to expand said prosthesis exclusively from one side with
respect to the elongated body and in order to leave free from said
expanded expandable portion the other side of the elongated
body.
4. Endolumenal device according to claim 1, in which the side of
the elongated body portion associated to the expandable portion and
free from said expanded expandable portion is provided with a
fissure suitable for forming a distal guidewire port of said at
least a guidewire lumen.
5. Endolumenal device according to claim 4, in which said fissure
is extended between a distal end and a proximal end of said
elongated body portion associated to the expandable portion.
6. Endolumenal device according to claim 1, in which the side of
the elongated body associated to the expandable portion and free
from the expanded expandable portion comprises a wall that
partially bounds said at least a guidewire lumen and is suitable
for being bored by a guidewire end in order to slip through the
bored portion of the wall said guidewire.
7. Endolumenal device according to claim 1, in which said at least
a guidewire lumen has a plurality of distal guidewire ports spaced
out along said elongated body.
8. Endolumenal device according to claim 7, in which said guidewire
tracking device comprise a plurality of guidewire lumens at least
one of which is associated to both of said distal guidewire
ports.
9. Endolumenal device according to claim 1, in which the guidewire
lumen has a distal apical guidewire port at the tip of said distal
end portion of the elongated body.
10. Endolumenal device according to claim 9, in which the guidewire
tracking device further comprises a first guidewire lumen and a
second guidewire lumen, at least one of said first guidewire lumen
and said second guidewire lumen being associated to a plurality of
distal guidewire ports, or side ports, provided on a side of the
elongated body opposed to the expandable portion.
11. Endolumenal device according to claim 9, in which the guidewire
tracking device comprises a single guidewire lumen associated to
said apical port.
12. Endolumenal device according to claim 1, in which the first
distal guidewire port is located near a distal end of the
expandable portion.
13. Endolumenal device according to claim 1, in which the at least
a guidewire lumen has at least a proximal guidewire port provided
in a portion of the elongated body located, with respect to the
expandable portion, at the opposite end from its distal end.
14. Endolumenal device according to claim 13, in which the
elongated body includes radio-opaque markers for the identification
of the position along said body of the distal and/or proximal
guidewire ports of the guidewire lumen.
15. Endolumenal device according to claim 1, in which the second
distal guidewire port is located near a proximal end of the
expandab1e portion.
16. Endolumenal device according to claim 1, in which said
expandable portion is a balloon.
17. Endolumenal device according to claim 16, in which said balloon
is functionally connected to an inflation lumen extending between
the proximal and distal end portions of the elongated body.
18. Endolumenal device according to claim 17, in which the proximal
end portion of the elongated body comprises a fluid connector,
which is in fluid communication with the inflation lumen and which
is adapted to functionally couple with a pressurizable fluid
source.
19. Endolumenal device according to claim 18, in which said
balloon, under the effect of the pressurized fluid, is expandable
eccentrically from one side or laterally with respect to the
elongated body in order to leave free from said expanded balloon
the other side of the elongated body.
20. Endolumenal device according to claim 19, in which said balloon
is in contact with the elongated body between its distal end and
its proximal end.
21. Endolumenal device according to claim 20, in which the entire
portion of the elongated body associated to the balloon is attached
internally to the wall of the balloon.
22. Endolumenal device according to claim 21, in which the entire
portion of the elongated body associated to the balloon is attached
externally to the wall of the balloon.
23. Endolumenal device according to claim 1, in which the elongated
body includes radio-opaque markers for the identification of the
position along said body of the first and second guidewire distal
ports of the at least a guidewire lumen.
24. Endolumenal device according to claim 1, in which the elongated
body includes radio-opaque markers for the identification of the
position along said body of a distal and/or proximal end of the
expandable portion.
25. Endolumenal device according to claim 1, in which said
expandable portion is suitable for holding a self-expanding
prosthesis in a radially collapsed position and releasing it in a
controlled manner so that it assumes a radially expanded
position.
26. Endolumenal device according to claim 1, wherein said plurality
of guidewire distal ports comprises a third guidewire distal port
located on a side of the elongated body opposed to the expandable
portion.
27. Endolumenal device according to claim 26, wherein the third
guidewire distal port is located between the first and second
guidewire distal ports.
28. Endolumenal device according to claim 1, wherein said plurality
of guidewire distal ports consists of only two guidewire distal
ports.
29. Endolumenal device according to claim 1, wherein the
endolumenal device is configured to prevent advancement of
substantially all of the expandable portion distal to the
bifurcation when the first guidewire port is advanced to the
bifurcation over a guidewire portion.
30. Endolumenal device for delivering and deploying an endolumenal
expandable prosthesis at a bifurcation provided with a main conduit
and at least a secondary conduit, comprising: an elongated body
having a proximal end portion and a distal end portion; the distal
end portion of said elongated body comprising an expansion device
having a proximal extremity, a distal extremity, and a
longitudinally extended active portion comprising a prosthesis
attachment region removably engageable with the endolumenal
expandable prosthesis and adapted to adjust said prosthesis from a
radially collapsed condition to a radially expanded condition said
expansion device comprising a distal end and a proximal end; a
guidewire tracking device at least partially extending along said
elongated body; wherein said active portion of the expansion device
is longitudinally associated to the elongated body in order to
expand said prosthesis eccentrically from one side with respect to
the elongated body, in order to leave free from said expanded
active portion the other side of the elongated body, and said
guidewire tracking device comprises at least a guidewire lumen at
least partially extending inside said elongated body, having at
least three guidewire distal ports including a first guidewire
distal port provided on a side of the elongated body distal of the
prosthesis attachment region of the expansion device and near a
distal end of the expansion device and opposed to the expansion
device and suitable for slipping through it a guidewire portion of
at least a guidewire placeable with its distal portion in said main
or at least a secondary conduit, said guidewire tracking device
also having a second guidewire distal port provided on a side of
the elongated body proximal of the prosthesis attachment region of
the expansion device and near a proximal end of the expansion
device for slipping through it a guidewire portion; said guidewire
tracking device also having a third guidewire distal port provided
on a side of the elongated body for slipping through it a guidewire
portion, the third distal guidewire port being located between the
first and second distal guidewire ports; wherein each of the first
guidewire distal port, the second guidewire distal port, and the
third guidewire distal port is located between the proximal
extremity and the distal extremity of the expansion device, and
said first guidewire distal port, said second guidewire distal
port, and said third guidewire distal port communicate with a
single guidewire lumen; and wherein the endolumenal device is
configured to prevent advancement of substantially all of the
expansion device distal to the bifurcation when the first guidewire
port is advanced to the bifurcation over a guidewire portion.
31. Endolumenal device according to claim 30, in which the
guidewire lumen has a distal apical port.
32. Endolumenal device according to claim 30, in which the elongate
body has a proximal end and further comprises proximal side ports
positioned in the portion of the elongated body that lies between
its proximal end and the expansion device.
33. Endolumenal device for delivering an endolumenal expandable
prosthesis at a bifurcation provided with a main conduit and at
least a secondary conduit, comprising: an elongated body having a
proximal end portion and a distal end portion, the distal end
portion of said elongated body comprising an expandable portion
having a proximal end and a distal end, the expandable portion
being engageable with the endolumenal expandable prosthesis and
adapted to adjust said prosthesis from a radially collapsed
condition to a radially expanded condition; a guidewire tracking
device at least partially extending along said elongated body, said
guidewire tracking device comprising at least one guidewire lumen
having a central longitudinal axis and a plurality of guidewire
ports opening from the lumen to an outside of the endolumenal
device to communicate with a blood vessel in use, said guidewire
ports suitable for slipping therethrough a guidewire placeable with
its distal portion in said main or at least a secondary conduit,
said expandable portion being disposed on one side of the central
longitudinal axis of the lumen and the plurality of guidewire ports
are disposed on another side of the longitudinal axis opposite the
expandable portion; and wherein at least two of the guidewire ports
are located between the proximal and distal ends of the expandable
portion.
34. The endolumenal device of claim 33, whererin the guidewire
tracking device comprises a first lumen and a second lumen for
advancement of a guidewire distal of the bifurcation in use.
35. The endolumenal device of claim 34, wherein the second lumen
extends proximally from an apical port located at the distal end of
the elongate body.
36. The endolumenal device of claim 34, wherein the second lumen
extends entirely within the elongate body from a distal portion of
the elongate body to a proximal end thereof.
37. The endolumenal device of claim 34, wherein the expandable
portion and the second lumen are positioned on the same side of the
central longitudinal axis of the first lumen.
Description
DESCRIPTION
The subject of the present invention is an endolumenal device for
delivering and deploying an endolumenal expandable prosthesis. In
particular, the present invention refers to a device for delivering
and deploying an endolumenal expandable prosthesis at a bifurcation
provided with a main conduit and at least a secondary conduit. Said
device comprises an elongated body having a proximal end portion
and a distal end portion. The distal end portion of said elongated
body comprises expansion means having a longitudinally extended
active portion removably engageable with the endolumenal expandable
prosthesis and adapted to adjust said prosthesis from a radially
collapsed condition to a radially expanded condition. The device
further comprises a guidewire tracking means at least partially
extending along said elongated body.
As is known, devices of the type described above are used for
delivering and deploying, meaning in particular fitting or
grafting, prostheses or stents endolumenally within conduit
systems, such as for example vessels carrying body fluids and, in
particular, lumens in the bodies of human beings and animals. Said
vessels for the transportation of fluids are, for example, arterial
blood vessels, such as coronary, peripheral and cerebral arteries,
veins or gastrointestinal tracts.
Using the abovementioned devices it is possible, for example, to
deploy endolumenal prostheses, or stents, in a vessel in which
atherosclerotic stenoses, or plaque, has partially or completely
occluded the lumen. Said prosthesis forms a radial support for the
surrounding wall of the lumen and prevents it partially or
completely occluding again, once it has been dilated by the
expansion means (balloon). These procedures are carried out using
known angioplasty techniques. Techniques of this type are, for
example, described in the publication "The New Manual of
Interventional Cardiology" edited by Mark Freed, Cindy Grines and
Robert D. Safian, Division of Cardiology at William Beaumont
Hospital, Royal Oak, Michigan; Physicians' Press 1996.
It is also known that the use of said techniques of angioplasty for
percutaneous revascularization is increasingly used as an
alternative to standard surgical procedures such as by-bass and
thromboendoatherectomy.
Stent use, originally limited to cases of acute periprocedural
complications following simple balloon angioplasty, such as
dissection, thrombosis and acute occlusion, now applies also to
elective treatment of coronary and systemic atherosclerotic
lesions.
The widespread use of these techniques is considerably limited by
the significant difficulties presented by the known endolumenal
devices when they are used on vascular ramifications or
bifurcations of the system of conduits (bifurcation lesions).
It is known that procedures on bifurcation lesions are frequently
subject to failures and acute complications, because the known
devices may cause occlusion of that branch of the bifurcation which
operates near the segment of the lumen in which the prosthesis is
fitted.
In particular, due to the activation of the expansion means in a
first branch of the bifurcation, the atheromatous material of the
plaques is protruded and displaced until it obstructs the ostium of
a second branch of the bifurcation, (a problem known as "snow-plow"
or "plaque-shifting").
Due to the abovementioned "snow-plow" or "plaque-shifting", the
ostium and the lumen of the occluded branch must again be rendered
accessible, or regained, by re-introducing a guidewire through a
barrier consisting of the plaque previously protruded and displaced
until it obstructed the lumen.
In other words, it is necessary, following the implanting of the
first prosthesis, to insert a second guidewire and a second
prosthesis into the occluded branch, passing through the mesh, or
struts, of the first prosthesis. Even when it is possible to regain
access to the occluded branch, the procedure becomes extremely
lengthy and, in any case, the results depend very much on the
experience of the surgeon.
Where the above described bifurcation lesions are present it is
therefore essential that the procedure is carried out in highly
qualified centres, fully equipped for cardiac surgery, that may be
called upon urgently in the case periprocedural complications or
lack of success in dilating the lesion or regaining the ostium of
the side branch.
Due to the abovementioned difficulties, the use of stents with wide
cells or apertures to allow the introduction of a guidewire into
the side branch and the passage of a second stent has been
proposed. However these wide cells can give rise to an increase in
prolapse of plaque material through the meshes, or struts, and,
therefore, to imperfect re-vascularization and increased
probability of re-stenosis.
One alternative is the simultaneous use of two devices fitted with
expansion means for the simultaneous insertion of two stents in
each of the branches of the bifurcation (paired or kissing
devices), or of a single bifurcated stent.
This known solution however is very bulky and difficult to
manoeuvre and can only be used in large vessels and in proximal
segments of the arterial tree. In other words, it is impossible to
use this known solution in peripheral branches, where the presence
of atherosclerotic plaques is more common. Furthermore, in order to
insert the known paired devices it is necessary to use
large-diameter guide-catheters. Said large diameter guide-catheters
induce an higher periprocedural risk. In addition, the greater bulk
of the paired devices occludes the vessel during insertion causing
ischemia during the procedure and making it impossible to inject an
adeguate amount of contrast medium which is useful for visualizing
the path for the correct positioning, first of the guidewire and
then of the endolumenal devices fitted with the prosthesis.
The use of paired devices also lacks versatility, above all in the
case of a single bifurcated stent, since the three vascular
segments which make up the bifurcation--the proximal main vessel,
the main vessel distal to the bifurcation and the secondary vessel,
or side branch--may be of very different bores with lesions of
varying lengths. It is therefore impossible at present to prepare a
range of bifurcated stents which can be adapted to all the possible
anatomical and pathological variables. It must also be noted that
these bifurcated stents, of fixed dimensions, often occlude other
branches near the bifurcation lesions, with consequent ischemia or
incomplete revascularization.
It is therefore evident that not all bifurcation lesions, and in
particular coronary bifurcation lesions, can be dealt with
percutaneously.
The above considerations show that the need for an endolumenal
device for delivering and deploying an endolumenal expandable
prosthesis, which can reach both the branches of a bifurcation
safely and rapidly, is widely felt.
Devices of this type are known from EP 0 897 700, WO 98 36709 and
WO 99 15103.
A need is likewise felt to be able to fit endolumenal prostheses
which are morphologically adaptable to the anatomy and to the
pathology of the proximal and distal portions of the branches of
the bifurcation. In other words, it is desirable to be able to deal
with all types of lesions using a single endolumenal device, of the
type described above, capable of adapting to a vast range of vessel
diameters and lesions of any length. Said endolumenal device must
also ensure the accurate deployment of the prosthesis, guaranteeing
wide coverage of the bifurcation, which prevents protrusion of
plaque material between the various prostheses fitted and the
formation of re-stenosis.
Therefore, the object of this invention is to devise and make
available an endolumenal device of the type specified above, which
will meet all the abovementioned requirements and, at the same
time, make it possible to avoid all the pitfalls outlined.
This object is achieved by means of an endolumenal device for
delivering and deploying an endolumenal expandable prosthesis at a
bifurcation provided with a main conduit and at least a secondary
conduit, comprising an elongated body having a proximal end portion
and a distal end portion; the distal end portion of said elongated
body comprising expansion means having a longitudinally extended
active portion removably engageable with the endolumenal expandable
prosthesis and adapted to adjust said prosthesis from a radially
collapsed condition to a radially expanded condition; a guidewire
tracking means at least partially extending along said elongated
body. Said device is characterised by the fact that said active
portion of the expansion means is longitudinally associated to the
elongated body in order to expand said prosthesis eccentrically
from one side with respect to the elongated body, in order to leave
free from said expanded active portion the other side of the
elongated body, and in that--said guidewire tracking means
comprises at least a guidewire lumen at least partially extending
inside said elongated body, having at least a guidewire distal port
provided on a side of the elongated body opposed to the expansion
means and suitable for slipping through it a guidewire portion of
at least a guidewire placeable with its distal portion in said main
or at least a secondary conduit.
The subject of the present invention also includes a method for
assembling out of an human body said endolumenal device to
guidewires, said guidewires being positioned along a common
proximal section of path and a diverging distal section of path,
forming a bifurcation between said sections, employing the
following stages: said endolumenal device is fitted onto a proximal
end of a first guidewire so that said first guidewire is received
in a guidewire lumen through a first distal guidewire port; said
endolumenal device is fitted onto a proximal end of a second
guidewire so that said second guidewire is received in the
guidewire lumen through a second distal guidewire port; said
endolumenal device is advanced along said guidewires until at least
part of the distal end portion of the elongated body is positioned
beyond the bifurcation of the guidewires.
The subject of the present invention also includes a method for
assembling out of an human body said endolumenal device to
guidewires, said guidewires being positioned along a common
proximal section and a diverging distal section of path, forming a
bifurcation between said sections, employing the following stages:
said endolumenal device is fitted onto a proximal end of a first
guidewire so that said first guidewire is received in a guidewire
lumen through a first distal guidewire port; said endolumenal
device is fitted onto a proximal end of a second guidewire so that
said second guidewire is received in the guidewire lumen through a
second distal guidewire port; said endolumenal device is advanced
along said guidewires until at least part of the distal end portion
of the elongated body is positioned on a distal diverging section
of path of one of the guidewires.
Further characteristics and advantages of the endolumenal device
according to the invention will become evident from the description
that follows of some preferred embodiments, which are given purely
by way of indication and without implying any limitation, with
reference to the enclosed drawings, in which: FIG. 1 shows a
partially sectioned view of the endolumenal device fitted with a
prosthesis; FIGS. 2 and 3 show a view from beneath, and a side
view, of a detail of the device of FIG. 1; FIGS. 4 and 4a show the
enlarged cross section on IV-IV of the device of FIG. 2, according
to two embodiments; FIG. 5 shows an end view along the arrow V of
the endolumenal device of FIG. 3; FIGS. 6a and 6b show a partially
sectioned view of the device of FIG. 1 during two stages of use;
FIGS. 7 and 8 show a view from beneath, and a side view, of a
detail of an endolumenal device according to a second embodiment;
FIG. 9 shows the enlarged cross section on IX-IX of the device of
FIG. 7; FIG. 10 shows a front view along the arrow X of the device
of FIG. 8; FIGS. 11a and 11b show a partially sectioned perspective
view of the device of FIG. 7 during two stages of use; FIGS. 12 to
17c show a section through a `T bifurcation` during eight stages in
the deploying of endolumenal prostheses; FIGS. 17d and 17e show in
section two alternative stages in the deploying of prostheses in
the bifurcation shown in FIG. 17c; FIGS. 18 to 23 show a cross
portion through a `Y bifurcation` during six stages in the
deploying of endolumenal prostheses; FIGS. 24 and 25 show a view
from beneath, and a side view, of an endolumenal device provided
with two distal ports at the distal end of the body beyond the
prosthesis; FIG. 26 shows an enlarged section on XXVI-XXVI through
the device of FIG. 24; FIG. 27 shows a view along the arrow XXVII
of the device of FIG. 25; FIGS. 28 and 29 show a view from beneath,
and a side view partially sectioned, of details of an endolumenal
device having a single guidewire lumen associated to distal ports
at the distal end of the body beyond the prosthesis; FIG. 30 shows
a view along the arrow XXX of the device of FIG. 29; FIGS. 31 and
32 show a view from beneath, and a side view partially sectioned,
of details of an endolumenal device having a plurality of guidewire
lumens associated to a plurality of distal ports; FIGS. 33 and 34
show a perspective view and a side view, in partial section, of an
endolumenal device having a single guidewire lumen associated to an
apical distal port and a plurality of distal ports spaced out along
the body; FIGS. 35 and 36 show a view from beneath, and a side view
partially sectioned, of details of an endolumenal device having a
first guidewire lumen associated to an apical distal port and a
second guidewire lumen associated to a plurality of distal ports
spaced out along the body; FIGS. 37, 38 and 39 show a view from
beneath, and a side view partially sectioned, and an enlarged
sectioned prospective of details of an endolumenal device having a
fissure suitable for realising a distal port; FIG. 40 shows a
perspective view, partially sectioned, during a stage in the
slipping of a guidewire proximal end into the body fissure of the
device of FIG. 38; FIGS. 41 to 45 show a cross portion through a
vessel during five stages in the deploying of an embolization
containment device and of an endolumenal prosthesis; FIG. 42c shows
a detail in an enlarged scale of FIG. 42a; FIG. 42b shows a cross
portion through a vessel during a stages in the deploying of an
embolization containment device according to a further embodiment;
FIG. 46 to 51 show a cross portion through a bifurcation during six
stages in the deploying of embolization containment devices and of
an endolumenal prosthesis; FIG. 52 shows a cross portion through
the coronary ostium during a stage in the deploying of an
endolumenal prosthesis; FIG. 53 to 55 show a cross portion through
a bifurcation during three stages in the deploying of endolumenal
prostheses by means of two endolumenal devices reciprocally
connected through a guidewire; FIG. 56 shows a perspective view,
partially sectioned, of an endolumenal device wearing a stent
provided with a differentiated spatial behaviour.
With reference to the above figures, the number 1 indicates as a
whole an endolumenal device for delivering and deploying an
endolumenal expandable prosthesis, or balloon catheter. For
example, said device is suitable for deploying an endolumenal
expandable prosthesis at a bifurcation provided with a main conduit
and at least a secondary conduit. The endolumenal device includes
an elongated body 2 having a distal end portion 3 and a proximal
end portion 4. For example, said elongated body 2 is between 100 cm
and 160 cm in length, and preferably between 115 cm and 140 cm. The
distal end portion 3 includes expansion means, 5, which can be
removably engaged with an endolumenal expandable prosthesis 6. Said
expansion means 5 can adapt said prosthesis 6 from a radially
collapsed to a radially expanded position, in a manner which will
be described in greater detail below. The expansion means 5 include
a distal portion 7 of the expansion means a proximal portion 8 of
the expansion means and a central portion 5a of the expansion means
to which the prosthesis 6 can be attached. The distal portion of
the elongated body 3 extends beyond the expansion means 5 in an
apical portion 9. At the proximal end of the proximal end portion 4
of the elongated body 2, there are means 10 for connecting the
endolumenal device 1 to an apparatus of a type known per se for the
controlled activation of the expansion means 5. The endolumenal
device 1 also includes guidewire tracking means 11 which extend at
least partially along the elongated body 2. For example, said means
11 extend along the distal end portion 3 of the elongated body 2
close to the expansion means, 5 (FIG. 1).
Advantageously, the active portion of the expansion means is
longitudinally associated to the elongated body in order to expand
said prosthesis eccentrically from one side with respect to the
elongated body, in order to leave free from said expanded active
portion the other side of the elongated body.
With further advantage, the guidewire tracking means 11 comprises
at least a guidewire lumen 12 or 13 that at least partially extends
inside said elongated body 2. Said lumen has at least a guidewire
distal port 15 provided on a side of the elongated body opposed to
the expansion means and suitable for slipping through it a
guidewire portion of at least a guidewire placeable with its distal
portion in a main or at least a secondary conduit.
In one embodiment of the invention, a first guidewire lumen 12 and
a second guidewire lumen 13 extend completely inside the elongated
body 2. Distal ports 14, 15 and proximal ports 16, 17 make said
first and second lumens 12, 13 able to receive guidewires 24, 25
(FIG. 19).
The distal ports 14, 15 are preferably spaced out along the
elongated body 2. For example, the distal port 14 of the first
guidewire lumen 12 is provided at the distal end of the apical
portion 9, and the distal port 15 of the second guidewire lumen 13
is provided near the distal end of the expansion means 5 (FIGS.
1-3, 6a, 6b, 18-23). The proximal ports 16, 17 are preferably
positioned in the portion of the elongated body 2 that lies between
its proximal end and the expansion means 5. For example, said ports
16, 17 are located at a distance ranging between 90 cm and 130 cm,
and preferably, between 105 cm and 115 cm, from the proximal end,
or from the connector means 10 (FIG. 1).
According to one embodiment, said endolumenal device is a balloon
catheter for angioplasty, 1. Said balloon catheter 1 comprises a
tubular catheter 2, a proximal connector 10, and an inflatable
balloon 5.
The catheter body 2 is tubular. The proximal portion 4 of said
tubular body 2 is designed to support and push the distal portion
3. Therefore said proximal portion 4 is less flexible than the
distal portion, which must be flexible in order to be able to enter
the peripheral branches of a vessel. For example, said proximal
portion 4 is made of a biocompatible material, such as biomedical
steel or nylon.TM.. Moreover, said proximal portion 4 is designed
to be received in a guide catheter (not shown and known per se)
which is necessary for maintaining accessibility of the lumen of
the vessel on which it is necessary to operate even when the
endolumenal device 1 is withdrawn. Said guide catheter is also
necessary for introducing, for example, a radio-opaque contrast
medium into the vessel. The proximal portion 4 of the catheter
body, 2 includes an inflation lumen, 18 (FIGS. 3, 4 and 4a, 6b).
Said lumen 18 extends from the proximal end of the catheter body 2
to the inflatable balloon 5.
The proximal connector, 10, for example a connector commonly known
as a "Luer", is provided at the proximal end of said portion 4 and
forms the abovementioned means of connection of the endolumenal
device 1 to the apparatus for the controlled activation of the
balloon 5. For example, said connector connects the inflation lumen
18 of the balloon 5 to a pressurized fluid source.
The balloon 5 is associated with the distal portion 3 of the
catheter body 2 to form an inflation chamber 19 which at least
partially surrounds the catheter body (FIG. 3). The inflation
chamber 19 is delimited by a balloon wall 20 equipped with an
external envelope 22. Said inflation chamber 19 is in communication
with the inflation lumen 18. In one embodiment, the balloon
includes, between a distal portion 7 and a proximal portion 8, a
central portion 5a. Said central portion 5a, when it is in a
radially expanded, or inflated position, is roughly cylindrical.
The balloon wall 20 in one embodiment is non-extendable or rigid
when subjected to pressurized fluid. Therefore the balloon wall 20,
when it is in a radially collapsed position, is folded around the
catheter body 2, for example it is threefolded or, in other words,
forms three folds 21 (FIG. 6a). By means of the external envelope
22, the balloon wall 20 can be removably fitted with an endolumenal
prosthesis. For example, the external envelope is removably fitted
with an endovascular stent, plastically deformable from a radially
collapsed condition to a radially expanded condition, which can be
fixed by pressure to the internal surface of a vessel wall. For
example, said stent is a metallic tubular stent comprising struts
or mesh. For this reason, the diameter of the central cylindrical
portion 5a, when the balloon is radially expanded or inflated by
pressurized fluid injected through the inflation lumen 18, is such
as to fix said prosthesis to the wall of the vessel by pressure
(FIG. 6b).
In a preferred embodiment of the invention, a longitudinal portion
of the balloon wall 20 is associated internally with the catheter
body 2. In other words, said wall 20 is fixed along its entire
length to the catheter body, so that when the balloon 5 changes
from the radially collapsed or deflated position to the radially
expanded or inflated position, said balloon 5 will extend
eccentrically or asymmetrically with respect to the catheter body
2, or in other words, on only one side of the body (FIGS. 3, 5 and
6b).
The distal portion 7 and the proximal portion 8 of the balloon 5
are advantageously tapered in shape. In particular, said portions
are truncated cones.
Advantageously, the tubular catheter body 2 comprises sheath means
or sleeve means 23, for example a flexible conduit. For example,
said sheath means are an integral part of the elongated body. The
sheath means 23 include a tubular body through which run a number
of longitudinal lumens, 12, 13 forming the abovementioned guidewire
lumens. The guidewire lumens 13, 14, or sections of these,
advantageously run in parallel along the elongated body. Said
lumens debouch at the extremities of the sheath means with the
abovementioned guidewire ports 14, 15, 16, 17. Said sheath means 23
are located inside the tubular catheter body 2 in such a way as to
leave a space (which forms the abovementioned inflation lumen 18)
along the entire length of that portion of the catheter body 2
which is situated between the proximal connector 10 and the balloon
5. Preferably, said sheath means are attached for their entire
length to the portion of the wall delimiting the balloon inflation
chamber (FIGS. 3, 4, 4a and 6b). In other words, where the tubular
elongated body of the catheter continues in the balloon wall, said
sheath means are associated to a portion of the balloon wall. In
one embodiment, said sheath means extend beside the balloon distal
portion becoming said catheter body apical portion. The extremities
of the sheath means 23 are attached to the wall of the catheter
body in such a way as to make the guidewire lumens accessible from
outside the catheter body through the guidewire ports.
It is particularly advantageous when said sheath means 23 debouch
in a first distal guidewire port 14, of a first guidewire lumen 12,
distant from a second distal guidewire port 15 of a second
guidewire lumen 13.
In particular, said sheath means extend to the tip of the distal
portion 3 of the catheter body 2 in such a way as to debouch with
the first distal guidewire port to the tip of the apical tract
9.
In a first embodiment of the invention, thanks to the asymmetrical
position of the balloon 5 with respect to the catheter body 2, the
second distal guidewire port 15 is positioned along the catheter
body 2 so as to allow the second guidewire lumen 13 to debouch at
the distal end of the central portion 5a of the balloon, or in
other words, so as to be positioned just outside the prosthesis 6
attachable to the balloon 5 (FIGS. 1 to 6b).
In a second embodiment of the invention, the second distal
guidewire port 15 is positioned along the catheter body in such a
way that the second guidewire lumen 13 debouches at a point located
between the distal portion 7 and the proximal portion 8 of the
balloon 5, and in particular at a point of the central portion 5a
attachable to the prosthesis 6. For example, said port 15 is
located near the centre line of said central portion 5a (FIGS. 7,
8, 11a and 11b). Preferably, the prosthesis 6, which can be
attached to said catheter 1, has a window 26 designed to prevent
obstruction of said distal guidewire port 15 when it is fitted on
the balloon 5. For example, the prosthesis 6 has a wider cell 26
than the other cells of the prosthesis, and at the same time of a
size close to that of the ostium of the lumen of the branch on
which it is necessary to proceed, or only slightly smaller.
Alternatively, the balloon can be fitted with a number of
prostheses, placed side by side in order to avoid obstructing said
port 15.
Preferably, the proximal guidewire ports 16, 17 are located in a
portion of the catheter body 2 which, during use of the catheter 1,
remains sheathed in the guide-catheter. For example, said proximal
guidewire ports are located at a distance from the tip of the
catheter ranging between 15 cm and 35 cm and, preferably between 20
cm and 30 cm. Alternatively, said ports 16, 17 are located at the
proximal end of the catheter body. In this case the balloon
catheter 1 is fitted with a proximal connector 10 with at least two
channels. A channel for the admission of the pressurized fluid into
the inflation lumen 18, and channels for passing the guidewires 24,
25 along.
Advantageously, radio-opaque markers, 30 and 31 are associated with
the catheter body 2 (FIG. 3). For example, said markers are located
along the catheter body 2 at the distal and proximal ends of the
prosthesis 6.
Said catheter body also includes radio-opaque markers for the
identification of the position along said body of the distal 14,
15, and/or proximal 16, 17 guidewire ports of the guidewire lumens
13, 14.
The subject of the present invention also comprises a kit for
delivering and deploying an endolumenal expandable prosthesis. Said
kit comprises an endolumenal device, 1, as described above, at
least a couple of guidewires 24, 25, and at least one expandable
prosthesis 6 radially associated with the expansion means 5 of said
endolumenal device 1. Said prosthesis comprises a tubular
prosthesis body adaptable from a radially collapsed condition, of
minimal external diameter, to a radially expanded condition, of
extended external diameter greater than the collapsed external
diameter.
For example, said kit for delivering and deploying an endolumenal
expandable prosthesis comprises at least one first radially
expandable prosthesis associated with the proximal portion of the
expansion means of said endolumenal device and also comprises at
least one second radially expandable prosthesis associated with the
distal portion of the expansion means of said endolumenal device,
or alternatively a single prosthesis overlapping said proximal and
distal portions of the expansion means.
Each of the guidewires of said kit includes means of
identification, such as for example the colour of at least a
proximal portion of the guidewire, or a diameter of the cross
section of a proximal portion of the guidewire which differs for
each guidewire.
Said guidewires advantageously comprise an elastically flexible
distal end portion.
In particular, said guidewires include initial proximal sections
which are positionable along a proximal section of path common to
all the guidewires, and secondary distal sections which are
positionable along distal sections of path which diverge and form
with said proximal section of path a bifurcation. It is
particularly advantageous for at least one of said guidewires to
include an elastically flexible distal portion, which extends at
least to straddle said bifurcation.
It is furthermore advantageous for said guidewires to include
radio-opaque markers, for example located near the tip of the
distal portion.
A description of the working of an endolumenal device according to
this invention follows.
In particular, the procedures necessary for guiding an endolumenal
device along guidewires 24, 25 are described below. Said guidewires
are located along a common proximal section of path and a diverging
distal section of path, forming a bifurcation between said
sections. The above method comprises the following stages: said
endolumenal device is fitted onto a proximal end of a first
guidewire so that said first guidewire is received in a first
guidewire lumen through its distal guidewire port; said endolumenal
device is fitted onto a proximal end of a second guidewire so that
said second guidewire is received in a second guidewire lumen
through its distal guidewire port; said endolumenal device is
advanced along said guidewires until at least part of the distal
end portion of the elongated body is positioned beyond the
bifurcation of the guidewires.
Advantageously, it is possible to envisage a further method of
guiding an endolumenal device along guidewires 24, 25, in which
said guidewires are positioned along a common proximal section of
path and a diverging, distal section of path, forming between said
sections a bifurcation. This further method includes the following
stages: said endolumenal device is fitted onto a proximal end of a
first guidewire so that said first guidewire is received in a first
guidewire lumen through its distal guidewire port; said endolumenal
device is fitted onto a proximal end of a second guidewire so that
said second guidewire is received in a second guidewire lumen
through its distal guidewire port; said endolumenal device is
advanced along said guidewires until at least part of the distal
end portion of the elongated body lies on a distal divergent
section of path of one of the guidewires.
The steps of a method for fitting radially expandable prostheses to
the walls of branches forming a `T bifurcation` 32 are described
below (FIGS. 12 to 17e). Said bifurcation 32 comprises a main
conduit 33 and a collateral conduit 34 that branches off from a
wall of the main conduit 33. The abovementioned method comprises
the following steps:
A kit as described above, and in particular a kit which comprises
an endolumenal device having a distal guidewire port located on a
central portion of the expansion means, is prepared.
Then, through a proximal section of the main conduit, a first
guidewire is positioned in the main conduit so that it passes the
bifurcation, and a second guidewire is positioned in the collateral
conduit. Said guidewires are positioned in such a way as to follow
an initial proximal section of path together and second distal
sections of path that diverge at said bifurcation (FIG. 12).
Next, a first endolumenal device, equipped with a radially
expandable prosthesis, is fitted onto a proximal end of the second
guidewire, so that said second guidewire is received in a guidewire
lumen of the endolumenal device, through a distal guidewire port
located on the tip of its elongated body.
Said first endolumenal device is inserted into said conduits
following the proximal and then the distal sections of path of the
second guidewire in order to position the radially expandable
prosthesis in the collateral conduit so that its proximal edge is
positioned near an ostium of said collateral conduit (FIG. 13).
Said expandable means are then activated so that said prosthesis is
in its radially expanded condition and fixed by pressure to the
wall of the collateral conduit (FIG. 14).
Next, said expansion means are withdrawn and the first endolumenal
device is withdrawn from the second guidewire until it has been
removed from the conduits.
A second endolumenal device equipped with a radially expandable
prosthesis is fitted onto a proximal end of the first guidewire so
that said first guidewire is received in a first guidewire lumen
through its distal guidewire port located on the tip of the
endolumenal device. Said second endolumenal device is fitted onto a
proximal end of the second guidewire so that said second guidewire
is received in a second guidewire lumen through its distal
guidewire port located on the portion of elongated body that lies
between a distal and a proximal end of the expansion means.
Said endolumenal device is inserted into the main conduit and slid
along the proximal section of path of the guidewires until a distal
portion of the endolumenal device, located between the tip of said
device and the distal guidewire port of the second guidewire lumen,
is positioned beyond the bifurcation (FIG. 16).
The expandable means of said second device are activated so as to
bring said prosthesis into its radially expanded condition and
fixed by pressure to the wall of the main conduit and straddling
the bifurcation (FIG. 17a).
Finally said expansion means are withdrawn and then the second
endolumenal device is withdrawn from the guidewires until it has
been removed from the conduits.
Further steps which make it possible to adapt the previously
grafted prostheses in order to cover the lesion completely are
described below.
A third endolumenal device without a prosthesis is fitted onto the
second guidewire, positioning it to straddle the bifurcation so
that a distal portion of the expansion means enters the collateral
conduit and a proximal portion of the expansion means is positioned
in the main conduit.
The expansion means of the third device are then activated so as to
adapt a portion of the prosthesis in the main conduit facing the
ostium or lateral window of the collateral conduit to the shape of
the lumen of said collateral conduit (FIG. 17c).
Said expansion means are withdrawn and then the third endolumenal
device is withdrawn from the second guidewire until it has been
removed from the conduits.
By inflating the third endolumenal device (for example a balloon
catheter for angioplasty) straddling the bifurcation, the struts of
the prosthesis grafted in the main conduit is moulded so that it
surrounds the ostium of the collateral conduit perfectly, and
guarantees perfect coverage of the lesion area (FIG. 17c).
Alternatively, particularly in the case of larger diameter or
larger bore conduits it is possible to insert two balloon catheters
simultaneously, fitting them on the guidewires 24, 25, so that they
are paired and straddle the bifurcation, one in the main conduit
and the second partially in the collateral conduit and partially in
the main conduit. Simultaneous expansion of the two balloons shapes
the prostheses so that they match and form a continuous support
structure which covers the entire extension of the lesion and
creates, in the area of the bifurcation, a funnel-shaped area which
joins the main and the collateral branches and promotes
non-vortical fluid flow in the conduits or vessels.
The stages of the method described above may also be reversed,
grafting first the main vessel and then the collateral vessel.
In view of the above procedures it is evident that the grafting of
a prosthesis in the main vessel shifts the plaque 39 material to
obstruct the ostium of the collateral vessel or vice versa (FIG.
14). Thanks to the fact that, using the device according to the
invention, the application of a first prosthesis in a vessel is
always carried out leaving a second guidewire in a second branch,
in spite of the presence in the ostium of the same of a barrier of
plaque caused by "snow-plow" or "plaque-shifting". It is therefore
always possible to insert in the second branch a device for the
application of a second prosthesis. Using known prior-art devices
it is not possible to operate simultaneously with two guidewires
always present in the two branches of the bifurcation, because a
second guidewire not positioned inside the prior-art device would
be externally jailed by the prosthesis and rendered unusable. In
other words, with the prior-art device it is necessary to proceed
using only one guidewire per procedural stage. With the device
according to the invention, however, it is possible to effect the
swift exchange of the endolumenal device on guidewires which always
remain in situ, it being possible to withdraw the endolumenal
device from a first branch of the bifurcation to reinsert the same
device or a second device in a second branch with extreme
rapidity.
The steps for a further method for fitting radially expandable
prostheses to the walls of the branches of conduits forming a `Y
bifurcation` 35 are described below. Said bifurcation comprises a
proximal main conduit 36 and a first and a second secondary distal
conduits 37, 38 which branch off from a distal end of the main
conduit, forming between them a carina. Said method comprises the
following steps.
A kit as described above is prepared, and in particular a kit
comprising an endolumenal device fitted with a distal guidewire
port located near the distal edge of a prosthesis fitted on the
expansion means, and a second distal guidewire port located at the
tip of the device, or apical port.
Through the main conduit first guidewire is positioned in the first
secondary distal conduit and a second guidewire in the second
secondary distal conduit, said guidewires being positioned so as to
follow a first proximal section of path together and second distal
section of path that diverge after said bifurcation (FIG. 18).
A first endolumenal device equipped with a radially expandable
prosthesis is fitted onto a proximal end of the first guidewire, so
that said first guidewire is received in a guidewire lumen of the
endolumenal device through its distal guidewire port located at the
tip of its elongated body.
Said first endolumenal device is fitted onto a proximal end of the
second guidewire so that said second guidewire is received in a
second guidewire lumen through its distal guidewire port located
near the prosthesis distal edge, just beyond the prosthesis.
Said first endolumenal device is inserted into said conduits
following the proximal section of path until the carina is
positioned against the elongated body and near the distal guidewire
port positioned near the distal end of the expansion means (FIG.
19).
Said expandable means are activated so as to bring said prosthesis
into its radially expanded condition, fixed by pressure to the wall
of the main conduit (FIG. 20).
Said expansion means are withdrawn and the first endolumenal device
is then withdrawn from the guidewires.
A second endolumenal device equipped with a radially expandable
prosthesis is fitted onto a proximal end of the first guidewire so
that said guidewire is received in a guidewire lumen through its
distal guidewire port located on the tip of said second endolumenal
device.
A third endolumenal device equipped with a radially expandable
prosthesis is fitted, at the same time as the second endolumenal
device, onto a proximal end of the second guidewire so that said
second guidewire is received in a guidewire lumen through its
distal guidewire port located on the tip of said third endolumenal
device.
Said second and third endolumenal devices are simultaneously
inserted into the main conduit and slid along the proximal section
of path of the guidewires and then along the respective distal
sections of path of said guidewires, until the expansion means are
positioned in a proximal portion of said first and second secondary
distal conduits, so that a proximal portion of the expansion means
is positioned near the carina. In particular, care is taken to
ensure that the proximal edge of both the second and third
prostheses is in contact with the distal edge of the first
prosthesis, already positioned and expanded in the main lumen (FIG.
21).
The expansion means of said second and third endolumenal devices
are activated in order to bring the respective prostheses into a
radially expanded condition fixed by pressure to the walls of said
first and second distal conduits (FIG. 22).
Said expansion means are withdrawn and then the second and third
endolumenal devices are withdrawn from the guidewires until they
have been removed from the conduits (FIG. 23).
The above description shows how the use of at least two guidewire
lumens which extend at least partially along the inside of the
elongated body makes it possible to fit the endolumenal device
simultaneously on at least two guidewires. In this manner, once at
least two guidewires have been inserted in the branches of a
bifurcation, it will be possible to insert and withdraw the
endolumenal device from a first branch of the bifurcation without
ever loosing rapid access to all the branches already negotiated,
i.e. reached by guidewires. In other words, it will be possible to
maintain uninterrupted access or vascular approach to all the
branches of the vascular system on which it is necessary to operate
and in which a guidewire has been inserted or, in yet other words,
using the device proposed it is no longer necessary to break
through the barrier of plaque 39 material which obstructs the
ostium of the branch by "snow-plow" or "plaque-shifting".
Thanks to the endolumenal device according to the invention it will
also be possible to position accurately a first endovascular
prosthesis in the main vessel always with precise positioning and
complete distension or application of the prosthesis over the
entire area of the lesion, thus reducing the probability of
re-stenosis and avoiding the pitfalls of the known techniques.
Advantageously, the endolumenal device proposed allows extreme
flexibility and modularity in the application of the endolumenal
prostheses. Thus, if the expansion means are positioned exactly
straddling the bifurcation it is possible to deploy endolumenal
prostheses of exactly the correct length and diameter for the
dimensions of the segment of damaged vessel to be treated, by means
of the proximal and distal portions of the expansion means.
With further advantage, each portion of the expansion means makes
it possible to graft a number of endolumenal prostheses of optimal
diameter and length for the anatomy of the damaged vascular
branch.
When expansion means fitted to the endolumenal prostheses are in
the collapsed position, the device according to the invention is of
reduced transverse bulk, making it possible to reach peripheral
branches extremely easily and rapidly (trackability).
Together with the versatility of application of prostheses adapted
to different branches of the bifurcation, the device proposed also
makes it possible to join prostheses, or, in other words, it allows
total coverage of the damaged area, avoiding prolapse of
atheromatous material and reducing the probability of
re-stenosis.
A further advantage derives from the fact that, using the
endolumenal device according to the invention, the geometry of the
prosthesis is not distorted and the vascular anatomy is respected.
In contrast, distortion of the prosthesis is inevitable when
endolumenal devices according to the prior art are used.
Obviously, variations and/or additions to what is described above
and illustrated may be envisaged.
Alternatively to a balloon with rigid walls threefolded onto the
catheter body for insertion into the lumen of a vessel, as
described above, it is possible to envisage the use of a compliant
or extensible balloon.
Other possible variations are: the catheter of the type described
above, "single-operator rapid exchange" or "monorail", may
alternatively be of the "over-the-wire" type, that is with opening
of the proximal guidewire lumens at the proximal end of the
elongated body; one of the at least two guidewire lumens may always
be occupied by a guidewire and may be inserted in the conduit, or
vessel, together with the endolumenal device. Preferably, in this
case the guidewire is fastened to or an integral part of the
elongated body of the endolumenal device, for example extending
from the apical portion of this ("fixed-wire"). the catheter may
also be of the perfusion balloon type in which passages are
provided for fluid flow when the balloon is inflated: these provide
communication between the portions of elongated body above and
below the expansion means (passages for the blood in the body to
prevent temporary occlusion of the vessel during the application of
the prosthesis and the inflation of the balloon). The endovascular
prosthesis may be modular. For example it is possible to provide a
series of prostheses of set diameters and a series of set lengths
which the operator can crimp to the proximal and distal portions of
the expansion means, making them extremely flexible or, in other
words, making it possible to adapt the prosthesis perfectly to the
pathological requirements of the moment, or in other words, to the
size of the lesion and the bore of the lumen of the vessel on which
it is necessary to operate.
As an alternative to the above description, illustrated by FIGS. 3
and 8, at least one portion of said at least a couple of guidewire
lumens 12, 13 forms a single guidewire lumen (FIGS. 28, 29, 30, 33
and 34).
In a further variation of the invention, a guidewire lumen 13 have
distal ports 15 located near the proximal end of the expansion
means, 5. Instead of the embodiment illustrated, for example, in
FIGS. 2 or 3, the elongated body is attached externally to the wall
of the balloon.
In a further embodiment of the invention, said expansion means are
designed to hold a self-expanding prosthesis in a radially folded
position and release it in a controlled manner so that it takes up
a radially expanded position. Said expansion means include a sheath
designed to receive in a sheath lumen said self-expanding
prosthesis. Said sheath can advantageously be adapted in controlled
manner from a first constricted position in which the
self-expanding prosthesis is confined in said lumen of the sheath,
to a second released position, in which said prosthesis is released
from said lumen of the sheath so that said prosthesis is radially
free, to bring itself into the radially expanded condition.
Such a device can be advantageously used in the artificial conduits
of biomedical equipment that connects up to the patient's body. For
example, a device of the type described above can be used for
transporting, positioning and deploying an element for the repair
of the walls of a conduit accidentally damaged during the use of
the abovementioned machinery.
Advantageously, the endolumenal device 1 comprises at least a
guidewire lumen 12 or 13 extended completely inside the elongated
body 2.
With further advantage, the active portion of the expansion means
is entirely associated to the elongated body in order to expand
said prosthesis exclusively from one side with respect to the
elongated body, and in order to leave free from said expanded
active portion the other side of the elongated body.
According to one embodiment, the side of the elongated body portion
associated to the expansion means and free from said expanded
active portion, or free side, is provided with a fissure 100
suitable for realizing a distal guidewire port 15 of the at least a
guidewire lumen 12, 13. It is furthermore advantageous for said
fissure 100 to be extended between the distal end and the proximal
end of the elongated body portion associated to the expansion means
5 (FIGS. 37, 38 and 39).
Preferably, the side of the elongated body associated to the
expansion means 5 and free from the expanded expansion means
comprises a wall 105 that partially binds said at least a guidewire
lumen 12,13. Said wall 105 is suitable for being bored by a
guidewire end 106, for example the proximal end, in order to slip
said guidewire 24 through the bored portion of the wall 105 (FIG.
40).
According to a further embodiment, the at least a guidewire lumen
12 and/or 13 of the tracking means has a plurality of distal
guidewire ports 14, 15, 15.sup.I, 15.sup.II, 15.sup.III, 15.sup.IV
and/or 15.sup.V, 15.sup.VI, 15.sup.VII, 15.sup.VIII, 15.sup.IX,
15.sup.X, 15.sup.XI, 15.sup.XII, 15.sup.XIII, 15.sup.XIV, spaced
out along said elongated body 2 (FIGS. 31, 32, 33, 34, 35 and
36).
Preferably, the guidewire tracking means 11 comprises a plurality
of guidewire lumens 12, 13, 13.sup.I, 13.sup.II, 13.sup.III
ssociated to each of said distal guidewire ports 14, 15, 15.sup.I,
15.sup.II, 15.sup.III, 15.sup.IV (FIGS. 31, 32).
Advantageously, the at least a guidewire lumen 12 and/or 13 has a
distal guidewire port 14, or apical port, at the tip of said distal
end portion 3 of the elongated body 2 (FIGS. 31, 32, 33, 34, 35 and
36).
With further advantage, a first guidewire lumen 12 associated to
said apical port 14 is provided in the body and a second guidewire
lumen 13 is associated to a plurality of distal guidewire ports 15,
15.sup.I, 15.sup.II, 15.sup.III, 15.sup.IV; 15.sup.V, 15.sup.VI,
15.sup.VII, 15.sup.VIII, 15.sup.IX, 15.sup.X, 15.sup.XI,
15.sup.XII, 15.sup.XIV, or side ports, provided on a side of the
elongated body opposite the expansion means (FIGS. 35 and 36).
As an extremely advantageous alternative, a single guidewire lumen
12, 13 associated to said apical port 14 is provided in the body
and is also associated to a plurality of distal guidewire ports 15,
15.sup.I, 15.sup.II, 15.sup.III, 15.sup.IV; 15.sup.V, 15.sup.VI,
15.sup.VII, 15.sup.VIII, 15.sup.IX, 15.sup.X, 15.sup.XI,
15.sup.XII, 15.sup.XIII, 15.sup.XIV, or side ports, provided on a
side of the elongated body opposed to the expansion means (FIGS. 33
and 34).
In a further variation of the invention, the at least a guidewire
lumen 13 has a distal guidewire port 15 near a distal end of the
expansion means 5.
Advantageously, the at least a guidewire lumen 13 has at least a
distal port 15, 15.sup.I, 15.sup.II, 15.sup.III, 15.sup.IV;
15.sup.V, 15.sup.VI, 15.sup.VII, 15.sup.VIII, 15.sup.IX, 15.sup.X,
15.sup.XI, 15.sup.XII, 15.sup.XIII, 15.sup.XIV in a portion of the
elongated body 2 that lies between a distal end and a proximal end
of the expansion means 5.
In a further variation of the invention, the endolumenal device can
be advantageously used in order to improve maneuvrability and
clinical efficacy of some embolization containment devices (ECD)
during coronary angioplasty and stenting.
Actually, a frequent complication of these procedures is the so
called "no-flow phenomenon", consisting of impairment of the blood
to flow down to the distal vessels, even though the obstruction has
been removed.
This calamitous event is mainly caused by the distal embolization
of the thrombus debris, and arterial spasms induced by some
vaso-constrictive substances released into the blood stream because
of the plaque crumbling and compression during balloon
inflation.
These events are frequent when treating recent coronary occlusions
in acute myocardial infarction, or when treating coronary lesions
with angiographic evidence of a thrombus within the lumen, as in
unstable angina.
Therefore, in addition to bifurcated lesion treatment, the proposed
device will find large scale application in the situations as
described here following.
Most ECD currently in use take the form of an occluding balloon 102
(FIG. 42b), or of a basket-shaped or an umbrella-shaped device 101
(FIG. 42c), which necessarily blocks the flow distally of debris,
and substances which can cause vasospasms.
An example of such application is described with the following
steps:
Step 1--a conventional guidewire (cGW) 24 is advanced beyond the
occlusion as a "trailblazer" for the ECD 101. In fact, these
devices have less maneuvrability and are more fragile than cGW 24
and, therefore, can't be used to bore, and to cross an occlusive
thrombus (FIG. 41).
Step 2--the ECD 101 is positioned as proximal as possible, but
sufficiently distant to permit the entrapment of the embolic
material and to allow easy handling and positioning of a
stent-delivery system, and finally, stent deployment. Furthermore,
positioning must be without excessive advancement of the ECD which
would allow embolic material to escape into lateral branches 34, if
positioned beyond vessel bifurcations.
Step 3--the ECD 101 is activated (i.e., the "umbrella" is opened or
the "balloon" inflated), after which the cGW is withdrawn, in order
to avoid its jailing between the stent and the vessel wall after
stent deployment (FIG. 42a).
Step 4--a conventional stent-delivery system is advanced using the
ECD 101 as a guidewire (FIG. 43).
Step 5--the stent-delivery system is inflated and the stent
deployed (FIG. 44).
Step 6--debris and vasospastic substances, released during the
stenting procedure, and entrapped by the ECD, are removed: with
suction using a dedicated probe which has been advanced until it is
contiguous with the occlusive "balloon", or withdrawn within the
"umbrella", after its closure (FIG. 45).
As clearly described, this technique presents some drawbacks: ECD
101, used as guidewire, give low support to the delivery systems
especially when they are positioned very proximally; a guidewire 24
repositioning could be needed after the stent deployment because of
procedural complications (such as dissections) or in order to treat
other lesions which come to light only after they has been
reopened. This procedure takes time and can be hazardous and
unsuccessful.
Therefore, leaving the guidewire 24 for the duration of the
procedure would be preferable.
All of this is easily performed with the proposed device 1 which
allows to ride both a cGW 24 (represented with a broken line in
FIGS. 43, 44 and 45) and a ECD 101 or 102 simultaneously, utilizing
the apical port 14 and a lateral or side port 15 provided on a side
of the elongated body of the expansion means 5 (FIGS. 35,36).
Therefore, we can leave a distally positioned cGW 24 for the
duration of the procedure, as an "auxiliary wire" to give more
support to the delivery system and to avoid re-crossing the stented
lesion, should this become necessary.
This proposed device also offers a significant clinical advantage
in the treatment of a thrombotic occlusion involving the ostium of
a branch, or just proximal to a vessel bifurcation (very frequent
cases), as shown in the following steps:
Step 1--the occlusion is crossed using a cGW 24 as a "trailblazer"
(FIG. 46);
Step 2--a first ECD 101 is advanced into a first branch 37 (FIG.
47);
step 3--a second ECD 101 is advanced into a second branch 38, and
both ECD are activated after the cGW 24 withdrawal (FIG. 48);
step 4--the proposed stent-delivery device 1 is advanced and
positioned with the simultaneous use of both ECD's as guidewires
(FIG. 49);
step 5--the stent is deployed and the vessel patency and the blood
flow restored (FIG. 50);
step 6--the debris and any substance released during the procedure,
entrapped by the 2 ECD's, are finally removed (FIG. 51).
Further clinical condition, where the device is extremely useful,
is in an ostial lesion at the origin of the right coronary artery
or a saphenous graft. In this case the engagement of a
guidecatheter 103 is impossible due to the narrowing of the lumen.
Therefore the guidecatheter 103 is positioned free in the middle of
the aortic lumen, opposite the ostium, where there are a continual
cardiac-cycle related movements of both the guidecatheter 103 and
the delivery system 1.
In such circumstances the stent positioning and deployment, using
the known devices, is necessarily imprecise and may improperly be
implanted, or may be the cause of failure of the procedure. So,
often times, these clinical situations are referred to surgeon for
aorto-coronary bypass grafting.
Utilising the proposed device 1, it is possible to attain a precise
positioning and deployment. The proposed method comprises:
positioning of a first guidewire 24 in the diseased vessel suitable
to fit it in the apical port 14 of a proposed device guidewire
lumen; then positioning of a second guidewire 25 free in the aortic
lumen and fitting said free guidewire in a proposed device side
port 15.sup.XIV, just proximal to a stent 6 crimped down on the
delivery system. In this way, the proposed device 1 can be advanced
in the right coronary artery until the emerging second guidewire 25
blocks the delivery system with the proximal edge of the stent 6
perfectly aligned with the aortic wall. By maintaining a constant,
even push until the stent delivery system (balloon) is activated
(inflated), it is possible to attain a stable positioning within
the ostial lesion and, therefore, the proper deployment of a
stent.
A further method of employment of the proposed device is in the
stenting of bifurcated lesions, where the proposed device 1 allows
the operator to implant simultaneously two stents 6.sup.I and
6.sup.II, perfectly flanked with their proximal edges on the same
level, utilizing a known "V" or "kissing" technique.
After having positioned guidewires 24, 25 in the respective
branches 37 and 38, a first guidewire 24 is fitted in a first
device through its apical port 14.
The same guidewire exits the device through a side port 15.sup.XIV,
proximal to the stent, and the first device is then advanced in the
first branch 37 (FIG. 53).
A second guidewire 25 is received in a second device through its
apical port 14. The first guidewire 24, received in the first
device, is subsequently fitted in the second device through its
side port 15.sup.XIV proximal to the stent (FIG. 54).
This second device is then advanced until it is "automatically"
blocked when its side port 15.sup.XIV arrives at vessel
bifurcation, where the two guidewires 24, 25 diverge. With a gentle
pulling back of the first device, the respective side ports
15.sup.XIV will be perfectly aligned and held in position by the
first guidewire 24, which exits the first device and re-enters the
second device.
In this way, the stents 6.sup.I and 6.sup.II, mounted on two
devices will necessarily be positioned with the proximal stent
edges at the same level and with a complete coverage of the
vascular "carina" between the two branches (FIG. 55).
Contrary to the "V" and "kissing" technique used with traditional
balloons, the proposed device allows an "automatic" and precise
positioning of paired stents, avoiding approximations, or that one
of the two delivery systems is dislodged by the other during
inflation of the balloons.
The proposed method of deployment is extremely efficient,
particularly if employed subsequently a preliminary deployment of a
stent 6 in the parent vessel, just proximal to the bifurcation; or
implanting in the two branches dedicated stents having
proximal-angled edges. In this way the coverage of the lesion is
improved, avoiding overlapping of the stents, and with a complete
coverage of the plaque (FIG. 55).
It is a further advantage that the proposed device has the
possibility to rotate in a controlled manner along its longitudinal
axis. In this way it is possible to properly orient and deploy
stents. Thus, even without a bifurcated lesion, with a guidewire 24
previously deployed in a side-branch (i.e. in a septal or diagonal
branch) it is possible to implant dedicated stents 103 with
variable structures along their circumference (i.e.: struts 104,
105 of variable widths or with different drug coatings 106, and
cells, with different diameter or dimensions, provided in different
region of the stent) thereby allowing a specific treatment of
selected areas in a single lesion.
A person skilled in the art could make numerous changes and
adaptations to the preferred embodiment of the endolumenal device
described above or substitute elements with others functionally
equivalent, in order to meet contingent and specific requirements,
without however departing from the scope of the following
claims.
* * * * *